The emerging markets have been making strides in developing pathways for the approvals of biosimilars. However, there are several considerations companies need to keep in mind when putting together a dossier for market approval in Russia, Colombia, Peru, and Malaysia.
While the annual meetings of the American Society of Clinical Oncology (ASCO) can almost always be counted on to generate news about scientific breakthroughs in understanding and treating cancer, the theme for this year’s conference goes beyond that conventional approach. ASCO 2016 Annual Meeting will prominently feature discussions about how clinicians can best integrate recent advances, and particularly how to best assess the impact on real-world patients.
The FDA has slightly revised its guidance on biosimilar naming following a period industry comments. What impact could this seemingly small tweak have on biosimilar makers' commercialization strategy?
The Biosimilars Forum recently launched its educational initiative known as the “Partnership for Biosimilar Education and Access.” Throughout the development of this initiative, it became clear to the Forum membership that physicians have specific educational needs that extend far beyond policy.
Throughout this whirlwind two-day event, the panelists addressed the challenges of patient education and uptake, the pharmacovigilance of biosimilars, and how to navigate varying regulatory requirements in the global market. But there were four key messages relayed throughout this conference that are worth noting.
A growing number of biopharma companies are becoming members of trade organizations. As Bert Liang, chair of the Biosimilars Council, discusses, the Biosimilars Council in particular has established goals that are focused on more than just the business aspect of market formation and the evolution of the regulatory pathways.
Samsung, the Korean computer chipmaker powerhouse, decided several years ago to pursue the emerging global biosimilar market. Although it's early, the company’s successful efforts to-date are reminiscent of a business arc the company perfected more than 30 years ago.
The Latin American markets, and especially Brazil, hold great promise for biosimilar development, PlantForm CEO Don Stewart says. In recent years, many partnerships have been launched in Brazil between local and international companies to bolster the country’s biosimilar development. However, there are a number of things companies looking to forge joint ventures in Brazil need to keep in mind for success.
Often, the thought of addressing computer system issues and data integrity evaluations becomes overwhelming to quality personnel, and thus these responsibilities are deferred to members of the IT department. I intend to simplify this topic and share some straightforward actions that firms can take to identify and correct deficiencies.
Roughly 15 to 20 years ago, a number of pharmaceutical companies raised money to employ tobacco technology in drug development. Unfortunately, this rush did not lead to the success many were hoping for. However, the successes of recent players in this space suggest pharma could be entering a new age in plant-based manufacturing.
With the explosion of the biologics market, which now accounts for an estimated 20% of all pharmaceutical sales, the industry has entered a new era of drug development. This growth — 10 percent to 15 percent each year — is being driven by monoclonal antibodies, which are anticipated to have worldwide sales of nearly $125 billion by 2021. However, this burgeoning market comes with some considerable challenges for drug manufacturers, due to the fragile nature and instability of these large, complex molecules.
It has only been short time – five years or so -- since immunotherapy first broke into the headlines following the approval of ipilimumab and later of nivolumab as monotherapy for melanoma and squamous lung cancer, respectively. Since then, as immunotherapies continue to show promise for other cancers, attempts to evaluate optimal tissue biomarkers to identify patients likely to benefit have also been an active area of research.
Although I’ve rarely traveled to shows since we launched Life Science Leader in 2009, I’m not unfamiliar with fulfilling this duty as an editor; I did it for six years prior to focusing exclusively on LSL. Still, there was one element of World Biosimilar Congress that seemed foreign to me — the role of the chairperson Richard DiCicco.
Successful prototyping begins with mechanical design that will operate properly when assembled and will be scalable for volume manufacturing. A working prototype can be a smooth progression if you employ the right resources and processes.
In this paper, we discuss how executing Phase III trials for biosimilars differs from that of New Chemical Entities (NCEs). Sponsors should understand from the outset that they will need to build in additional planning time and adopt tailored strategies for assessing feasibility, selecting sites, recruiting patients, procuring the comparator product, and ensuring the integrity of the study blind.
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